|
 |
The Ministry of Health and Family Welfare declared the following sterile devices
to be considered as drugs :
Cardiac Stents , Drug Eluting Stents , Catheters , Intra Ocular Lenses , I.V.
Cannulae , Bone Cements , Heart Valves , Scalp Vein Set , Orthopedic Implants
and Internal Prosthetic replacements.
Procedures for import as well as manufacturing of these medical devices have
been defined , the details about which are given in this issue.
As per Mr Milind Shah, managing director, Medtronic's Indian operations , " the
notification will allow market to grow and help patients access the best
available to diagnosis, monitor and recover at a faster pace. Regulatory
approval for medical devices has to be made mandatory in India. There is a need
for regulation in India as globally all medical devices undergo stringent
quality norms." |
|
Another important announcement is related to "National Drug Authority ". The
government of India is planning to spend about Rs 360 crore in the next
four-five years in capacity building of the proposed healthcare and pharma
regulator, National Drug Authority (NDA). "This will enable recognition of R&D
activities being undertaken in the Indian pharma and healthcare sector in the US
and other countries," Union minister for health, Anbumani Ramadoss said at the
launch of the first management consultation on health care in IIM, Ahmedabad ,
last month.
While these changes will certainly help support Indian Industry to get
recognition in the global markets , it is very important that the regulators
also keep in mind the size and shape of the domestic Industry particularly the
large number of small scale medical disposables' manufacturing units. It is
therefore very essential to increase the interaction between policy-makers,
academicians, practitioners, administrators and members of industries associated
and involved with healthcare , specifically , medical device industry.
Along with other regular features , this issue also gives an overview of medical
device industry in USA as well as China.
D.L. Pandya
|
